Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00724386
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Paclitaxel Drug: Vinorelbine Drug: Filgrastim Radiation: Radiation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
Study Start Date : June 1999
Actual Primary Completion Date : October 2005
Actual Study Completion Date : November 2012

Intervention Details:
  • Drug: Paclitaxel
    1-hour IV infusion once weekly for 12 to 14 weeks
    Other Name: Taxol
  • Drug: Vinorelbine
    escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
    Other Name: Navelbine
  • Drug: Filgrastim

    daily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12).

    For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject

  • Radiation: Radiation
    Radiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy

Primary Outcome Measures :
  1. feasibility of administering study therapy to limit skin toxicity [ Time Frame: 4 weeks ]
  2. dose-limiting toxicity [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. response [ Time Frame: 14 weeks ]
  2. time to progression
  3. overall survival
  4. Bcl-2 detection by immunohistochemistry [ Time Frame: 14 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:

    1. patients with locally advanced unresectable stage IIIa or IIIb;
    2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
    3. patients with metastatic disease AND uncontrolled locoregional disease are eligible.
  • Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
  • Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
  • 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
  • Aged 18 years or older
  • CALGB performance status of 0 - 2
  • Life expectance of at least 12 weeks
  • Initial Laboratory Data:

    • ANC Count > 1500/mm3
    • Platelet Count > 100,000/mm3
    • Creatine ≤ 2.0 mg/dl
    • Bilirubin ≤ 1.5 mg/dl
    • ALT (SGPT) ≤ 3 times the upper limit of normal
  • Signed informed consent

Exclusion Criteria:

  • Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
  • Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
  • Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
  • No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00724386

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Responsible Party: University of Chicago Identifier: NCT00724386     History of Changes
Other Study ID Numbers: UCIRB 9849
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs